Bayer Settling Trasylol Lawsuits, Report Says

About 150 <"">Trasylol lawsuits have been settled by Bayer AG for at least $60 million, according to Bloomberg News. According to three anonymous sources, the settlements provide an average payout of about $400,000 per patient, the report said.

Trasylol, was approved by the US Food & Drug Administration in 1993. It was used to prevent bleeding during heart bypass surgery, but was permanently withdrawn from the market in 2008. By that time, Trasylol had been used in a third of all heart surgery patients in the US.

Following its approval, the safety of Trasylol was reviewed several times. In October 2007, the Canadian Data Safety Monitoring Board stopped a Trasylol trial – known as the BART clinical study – after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.

Bayer decided to take Trasylol off the market for good after an analysis of the Canadian study was published in a May 2008 issue of The New England Journal of Medicine. The analysis found that of the 2,331 people enrolled in the Canadian study, the death rate among Trasylol patients was 6 percent, while the rate for those being treated with other drugs – namely Amicar or Cyklokapron – was 4 percent. That represented an increased death rate of 53 percent for Trasylol patients, which translates to one extra death for every 50 patients treated with Trasylol.

According to the Bloomberg report, Bayer faces at least 1,600 suits alleging the company hid Trasylol’s risks from patients and doctors. In April, a lawyer for Bayer announced at a hearing in federal court in Palm Beach, Florida that the company had devised a “settlement program aimed at resolving not just one or two cases at a time, but to provide an overall framework for resolving the litigation,” Bloomberg said. At that time, the attorney said Bayer had settled 63 Trasylol lawsuits.

According to today’s report, a Bayer spokesperson told Bloomberg via email that 120 such lawsuits have been settled. The company would not comment on the size of the settlements, however.

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